DPD Defibrillator
FDA 510(k) K930548 · Medical Research Laboratories, Inc.
510(k) numberK930548
Submission
- Device name
- DPD Defibrillator
- Applicant
- Medical Research Laboratories, Inc.
Buffalo Grove, IL, US - Received
- February 3, 1993
- Decision date
- June 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K102468 | Zoll Propaq MDLDD · Special | Zoll Medical Corporation, World Wide Headquarters | 09/30/2010SE |
More from Zoll Medical Corporation, World Wide Headquarters
| 510(k) | Device | Decision |
|---|---|---|
| K021168 | Jump Start, Model 970300MKJ · Traditional | 06/26/2002ST |
| K012766 | Portable Intensive Care UnitMKJ · Traditional | 01/23/2002ST |
| K012030 | Portable Intensive Care UnitMKJ · Traditional | 09/24/2001SE |
| K010207 | Portable Instensive Care UnitMKJ · Special | 06/14/2001ST |
| K002232 | AedefibrillatorMKJ · Traditional | 12/06/2000SE |
| K000712 | Portable Intensive Care Unit, Model PicCCK · Special | 04/27/2000SE |
| K983307 | Modification to Portable Intensive Care UnitMKJ · Special | 11/20/1998SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | 03/02/1998SE |
| K952085 | DPD DefibrillatorLDD · Traditional | 06/05/1995ST |
| K935922 | 360 SLX Advisory DefibrillatorMKJ · Traditional | 12/22/1994SE |
Questions and answers
When was DPD Defibrillator cleared by the FDA?
DPD Defibrillator (K930548) received a 510(k) decision of Substantially Equivalent on June 25, 1993, 142 days after the submission was received.
What is the product code of K930548?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.